# K101091: Z.One Ultra Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Zonare Medical Systems, Inc.
- Decided: Jun 25, 2010 after 67 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K935595 (1995). 81 ancestors in all.
132 later devices descend from it; 5 cite it directly.
0 of 214 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022858: Supernova Diagnostic Ultrasound Scanning System, Novasonics, Inc. (2002) Summary page 1.
- K082326: Zonare Ultra Ultrasound System, Zonare Medical Systems, Inc. (2008) Summary page 1.
- K031066: Viewmate Ultrasound Imaging System, Ep Medsystems (2003) Summary page 1.
- K073709: Modification to Viewmate System, Ep Medsystems (2008) Summary page 1.
- K062247: HD11 Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2006) Summary page 1.
- K053069: Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series), Sonosite,Inc. (2005) Summary page 1.

## Most influential descendants
- K121699: Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound System (2012), 98 descendants of its own
- K123622: Acuson (2012), 96 descendants of its own
- K123001: Acuson X700 Diagnstic Ultrasound System (2012), 74 descendants of its own
- K132804: Acuson S1000 / S2000 / S3000 (2013), 73 descendants of its own
- K140959: Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems (2014), 60 descendants of its own

## Indications for use
The device is intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal/obstetric, gynecological; Abdominal (renal, GYM/Pelvic; Intra-operative (abdominal, thoracic, and vascular), Intra-operative neurological; Pediatric; Small organ (thyroid, breast, testes, etc), Adult & Neonatal Cephalic; Trans-rectal, Trans-vaginal, Trans-cranial, Trans-esophageal (non-cardiac and cardiac); Musculoskeletal (conventional & superficial); 3D/4D; Cardiac - Adult/Pediatric/Fetal; Intra-Cardiac; Pelvic; Peripheral vascular; harmonic tissue and contrast imaging and Tissue elasticity..

Source page: https://510kreport.com/device/K101091
Methodology: https://510kreport.com/methodology